FDA 510(k)

ELECTROmatic

K-Number: K163317 · 2017-02-21

Decision Date2017-02-21

Product CodeEBW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ELECTROmatic is the device name listed in this FDA 510(k) record. The listed applicant is Kaltenbach & Voigt Gmgh. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K163317. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROmatic?

ELECTROmatic is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Kaltenbach & Voigt Gmgh. The 510(k) number is K163317.

When did ELECTROmatic receive FDA 510(k) clearance?

ELECTROmatic received FDA 510(k) clearance on 2017-02-21, under 510(k) number K163317.

Who is the listed applicant for ELECTROmatic?

The FDA 510(k) record lists Kaltenbach & Voigt Gmgh as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROmatic?

The FDA product code for ELECTROmatic is EBW.

Related Devices (Code: EBW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.